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An Approach to Pharma Method Validation for Direct Mass Spectrometry

SelectScience
14 Jan 2019
Emily Adam
Publishing / Media

Expert insights

Volatile compounds are common impurities in pharmaceutical products and are often of concern due to their toxicity. They can also represent a health and comfort hazard, both indoors and out. However, analysis using conventional chromatographic methods is slow, due to both sample preparation and chromatography.

SIFT-MS is a new analytical tool for real-time, selective, and economical trace gas and headspace quantification of volatile compounds, including chromatographically challenging ones, such as formaldehyde, formic acid, and ammonia.

But how do you approach analytical method validation for SIFT-MS so that the data can be used to support regulatory requirements? By applying a strategic method in accordance with ICH Q2(R1) guidelines to direct SIFT-MS methods – and utilizing formaldehyde analysis as a case study – successful validation is readily achieved.

Join us for this webinar to learn more about how SIFT-MS works, how it speeds up analysis, and how it can be validated successfully in accordance with ICH Q2(R1) guidelines suitable for pharmaceutical applications, such as regulatory submissions where GMP compliance is essential.

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Key learning objectives:

  • Learn the fundamentals of the selected ion flow tube mass spectrometry (SIFT-MS) technique, including its ability to selectively and comprehensively analyze samples in one, simple procedure
  • Discover how direct SIFT-MS analytical methods can be validated in accordance with ICH Q2 (R1) guidelines so that the data generated is GMP compliant and can be used in regulatory submissions
  • Understand the application of this validation approach through a case study covering formaldehyde quantification in the headspace of a packaged pharmaceutical product

Who should attend?

  • Analytical chemists
  • QA/QC managers and scientists
  • Method developers and validators
  • Researchers / R&D managers
  • Laboratory managers / directors / supervisors
  • Analytical outsourcing managers

Interested, but have a scheduling conflict? Register to watch the webinar on demand at a time more suitable for you.

SelectScience runs 3-4 webinars a month across various scientific topics, discover more of our upcoming webinars>>

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Mass SpectrometryMass spectrometry (MS) is a powerful analytical technique used to identify and quantify molecules based on the mass-to-charge ratio of gas-phase ions. It provides detailed information about the structure, composition, and properties of compounds and is widely used across fields such as environmental monitoring, materials science, drug discovery and development, food and beverage testing, and wider chemical research. Key MS techniques include tandem mass spectrometry (MS/MS), liquid chromatography–mass spectrometry (LS-MS) and inductively coupled plasma (ICP-MS). Choosing from these wide range of techniques and technologies can be a daunting task, so keep up to date with scientific applications, performance expectations, and customer reviews here all in one place. Visit our product directory to receive quotes direct from the manufacturer. Drug DiscoveryDrug discovery is the process of identifying potential new medications, involving stages such as target identification, compound screening, and preclinical development. It relies on cutting-edge technologies like high-throughput screening, artificial intelligence, and molecular modeling to accelerate the identification of drug candidates. Drug discovery plays a pivotal role in developing new therapies for diseases ranging from cancer to rare genetic disorders. Browse our peer-reviewed product directory to find the latest drug discovery technologies, compare options, check customer feedback, and get pricing directly from manufacturers.

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An Approach to Pharma Method Validation for Direct Mass Spectrometry